meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
58
Latest Decision
2016-05-17

Clearances · page 23 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K160356 Third Eye Panoramic Auxiliary Endoscopy System - Resposable Avantis Medical Systems, Inc. FDF Class II 2016-05-17
K160419 Monoject Enteral Feeding Syringe with ENFit Connector Covidien PNR Class II 2016-05-12
K161017 True HD 3MOS Camera System Conmed Corporation GCJ Class II 2016-05-09
K153506 Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit Consure Medical Pvt , Ltd. KNT Class II 2016-05-06
K160740 Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology Surgical Instrument Service and Savings, Inc. NLM Class II 2016-05-06
K160773 Yarlap II International Trade Group, Inc. KPI Class II 2016-05-04
K160654 GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) Covidien, LLC KNT Class II 2016-05-04
K161203 Soehendra Stent Retriever Wilson-Cook Medical, Inc. FGE Class II 2016-05-04
K160845 Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device Boston Scientific Corporation ODG Class II 2016-05-03
K160725 EndoFLIP Crospon, Ltd. FFX Class II 2016-05-01
K160960 EsophyX® Z Device with SerosaFuse Fasteners and Accessories Endogastric Solutions, Inc. ODE Class II 2016-05-01
K152619 Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) Prosurg, Inc. GCJ Class II 2016-04-29
K152892 da Vinci Xi Surgical System Intuitive Surgical NAY Class II 2016-04-29
K151086 ManoScan System Given Imaging , Ltd. FFX Class II 2016-04-28
K153449 2008K2 Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC KDI Class II 2016-04-26
K160858 CompactCath Intermittent Urinary Catheter Compactcath, Inc. EZD Class II 2016-04-26
K160172 Laparoscope Lens Shield Device Medeon Biodesign, Inc. GCJ Class II 2016-04-21
K153698 LumenR Tissue Retractor System Lumenr, LLC ODB Class II 2016-04-19
K153655 Accuryn Monitoring System Potrero Medical, Inc. EZL Class II 2016-04-15
K160749 CRIT-LINE III Blood Chamber II Fresenius Medical Care Renal Therapies Group, LLC KOC Class II 2016-04-15
K153084 Nephros S100 Nephros, Inc. NHV Class II 2016-04-08
K151503 NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE Gbuk Enteral Limited PIF Class II 2016-04-05
K153258 Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars Surgical Instrument Service and Savings (Dba Medline Renewal NLM Class II 2016-04-05
K151967 Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter Merit Medical Systems, Inc. MSD Class II 2016-04-04
K151832 NOVATECH TALCAIR Novatech SA GCJ Class II 2016-03-31
K160861 Proxis Ureteral Access Sheath C.R. Bard, Inc. FED Class II 2016-03-31
K160637 Rotatable Snares Boston Scientific Corporation FDI Class II 2016-03-30
K152578 da Vinci Surgical System, Model IS4000 Intuitive Surgical, Inc. NAY Class II 2016-03-30
K152105 Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set Rocket Medical Plc PNG Class II 2016-03-29
K153337 Corvocet Biopsy System Merit Medical Systems, Inc. KNW Class II 2016-03-25
K160098 Single Use Aspiration Needle NA-U401SX Olympus Medical Systems Corp. FCG Class II 2016-03-22
K160229 Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle Cook Ireland, Ltd. FCG Class II 2016-03-21
K152938 DBB-06 Hemodialysis Delivery System NIKKISO CO., LTD. KDI Class II 2016-03-18
K160417 Rezum System Nxthera, Inc. KNS Class II 2016-03-17
K152598 Endo Keeper Nelis OTJ Class II 2016-03-17
K153584 NeoTract UroLift System UL500 Neotract, Inc. PEW Class II 2016-03-15
K152448 da Vinci Single-Site Instrument and Accessories Intuitive Surgical, Inc. NAY Class II 2016-03-09
K152421 IS4000 Stapler 30 Instrument and Stapler 30 Reloads Intuitive Surgical, Inc. NAY Class II 2016-03-04
K153206 Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 Fujifilm Medical System U.S.A., Inc. FDS Class II 2016-03-03
K151745 FULL CARE Disposable PVC Nelaton Catheter Shaoxing Fuqing Health Products Co., Ltd. EZD Class II 2016-03-03
K160241 Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 Olympus Medical Systems Corp. KNS Class II 2016-03-02
K160230 VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm Covidien GCJ Class II 2016-03-01
K143482 xevonta dialyzer B. Braun Avitum AG KDI Class II 2016-03-01
K152989 Mammotome revolve Dual Vacuum Assist Biopsy System Devicor Medical Products, Inc. KNW Class II 2016-02-25
K150304 Oxyless Blood Tubing Set Oxyless, Ltd. FJK Class II 2016-02-24
K153588 EndoChoice Water Bottle Cap System Endochoice, Inc. FEQ Class II 2016-02-24
K160198 UreTron MultiProbe Lithotripter System Med-Sonics Corp. FFK Class II 2016-02-23
K160196 Fujifilm Video Colonoscope Model EC-600WL V2 Fujifilm Medical Systems U.S.A, Inc. FDF Class II 2016-02-23
K153384 Low Potassium Dextran Solution with Tris Diluent United Therapeutics Corporation KDN Class II 2016-02-19
K151474 Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) Fujifilm Medical System U.S.A., Inc. KGE Class II 2016-02-18
K152596 Intact® Gen2 System Intact Medical Corporation KNW Class II 2016-02-15
K150487 X-Suit NIR Biliary Metallic Stent Medinol, Ltd. FGE Class II 2016-02-12
K153625 Single Use Injector NM600/610 Olympus Medical Systems Corp. FBK Class II 2016-02-12
K153218 Arthrex Synergy UHD4 System Arthrex, Inc. GCJ Class II 2016-02-12
K151308 Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set Schoelly Fiberoptic GmbH FGA Class II 2016-02-09
K151635 CapsoCam (SV-1) CapsoVision, Inc. NEZ Class II 2016-02-09
K151237 Nutrisafe 2- ENFit Adaptor Vygon PIO Class II 2016-02-09
K151772 Actreen Mini Intermittent Urinary Catheters B.Braun Medical, Inc. GBM Class II 2016-02-09
K152278 ENDOFLOW II - Irrigation, Warming and Suction System Promepla Sam OCX Class II 2016-02-09
K151475 EndoChoice Select Injection Needle Endochoice, Inc. FBK Class II 2016-02-08
K152948 Medline Anti-Fog Solution Medline Industries, Inc. OCT Class II 2016-02-04
K151036 Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments Carefusion 2200, Inc. GCJ Class II 2016-02-01
K160044 Image1 SPIES System Karl Storz Endoscopy America, Inc. FET Class II 2016-02-01
K152149 VersaOne Bladed Trocar 5mm Covidien GCJ Class II 2016-01-22
K152400 General & Plastic Surgery Instruments Sontec Instruments, Inc. GCJ Class II 2016-01-22
K152802 Grasping Forceps Micro-Tech (Nanjing) Co., Ltd. OCZ Class II 2016-01-21
K151620 Firefly Peritoneal Dialysis Connector Disinfection System Puracath Medical, Inc. KDJ Class II 2016-01-20
K151794 da Vinci Xi Surgical System Intuitive Surgical, Inc. NAY Class II 2016-01-15
K143153 EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V Olympus Medical Systems Corp. FDT Class II 2016-01-15
K153466 PillCam COLON 2 Capsule Endoscopy System Given Imaging , Ltd. PGD Class II 2016-01-14
K151282 core nova Complete Operating Room Endoscopy Richard Wolf Medical Instruments Corp. ODA Class II 2016-01-12
K151051 Universa Soft Ureteral Stents and Stent Sets Cook Incorporated FAD Class II 2016-01-11
K151084 Well Lead Ureteral Access Sheath Well Lead Medical Co., Ltd. FED Class II 2016-01-07
K152872 K2M Fenestrated Tap System K2m KNW Class II 2016-01-05
K153190 Zenysis Short-Term Dialysis Catheter C.R. Bard, Inc. MPB Class II 2016-01-05
K142125 New Medax Biopsy Systems Medax Srl Unipersonale KNW Class II 2015-12-22
K150831 Cellvizio 100 Series System with Confocal Miniprobes Mauna Kea Technologies OWN Class II 2015-12-22
K153306 Imbibe Needle Orthovita, Inc. KNW Class II 2015-12-18
K153344 Asahi REXEED-S Series Dialyzer Asahi Kasei Medical Co., Ltd. KDI Class II 2015-12-17
K152857 NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps Neomed, Inc. PNR Class II 2015-12-17
K153362 AquaShield system CO2, AquaShield system-PENTAX United States Endoscopy Group, Inc. FEQ Class II 2015-12-16
K152513 8X-10-XXXX Camera System Santa Barbara Imaging Systems GCJ Class II 2015-12-15
K153483 Balloon controller PB-30 Fujifilm Medical Systems U.S.A, Inc. FDF Class II 2015-12-15
K153461 Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm Maquet Critical Care AB KNT Class II 2015-12-11
K153088 AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System Boston Scientific Corporation PCU Class II 2015-12-11
K152001 Sterile Repositionable Hemostasis Clipping Device Micro-Tech (Nanjing) Co., Ltd. PKL Class II 2015-12-10
K150708 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC KDI Class II 2015-12-10
K152182 Fuse Gastroscopy System Endochoice, Inc. FDS Class II 2015-12-10
K153126 da Vinci Xi Hasson Cone Intuitive Surgical, Inc. GCJ Class II 2015-12-09
K150966 HMB32 Haemopharm Biofluids S.R.L. KPO Class II 2015-12-04
K151714 Disposable Endoscope Valves Set A Wilson Instruments (Shanghai) Company Limited ODC Class II 2015-12-03
K150618 PENTAX Medical EPK-i7010 Video Processor with GI Family Pentax of America, Inc. PEA Class II 2015-11-24
K151191 OES ELITE Telescopes, Protective Tube Olympus Winter & Ibe GmbH FBP Class II 2015-11-24
K150550 SilverCoat Silicone Foley Catheter Covalontechnologies, Inc. EZL Class II 2015-11-24
K151738 Single Use Aspiration Needle NA-U200H Olympus Medical Systems Corp. FCG Class II 2015-11-20
DEN150001 RELIZORB Alcresta, Inc. PLQ Class II 2015-11-20
K152853 WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary Boston Scientific Corp FGE Class II 2015-11-20
K152848 AUTOLAP SYSTEM M.S.T Medical Surgery Technologies, Ltd. GCJ Class II 2015-11-17
K153049 LithoVue System Boston Scientific Corporation FGB Class II 2015-11-13
K150558 Eclipse System Pelvalon, Inc. PJH Class II 2015-11-12

11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.